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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

Criteria for assessing PBT properties are defined in Annex XIII, REACH Regulation (EC) No. 1907/2006. Further details are laid down in ECHA Guidance on Information Requirements and Chemical Safety Assessment; Chapter R.11: PBT Assessment (May 2008). The assessment of PBT / vPvB properties is based upon a separate assessment for each parameter (i.e. P or vP, B or B and T). Substances are only assigned as PBT or vPvB when they fulfil the criteria for all three properties (persistency, bioaccumulation and toxicity in case of PBT substance) or both criteria (i.e. very persistent and very bioaccumulative) in case of vPvB, respectively.

Based on biodegradability test results (readily biodegradable) and reliable supporting QSAR information, Butylaminoethanol is considered neither as persistent (not P) nor as very persistent (not vP). The B criterion (bioaccumulative substance) is not fulfilled, due to the experimentally determined logPow of 0.64 (BASF AG, 1993) and the predicted Bioconcentration factor (BCF) far below the trigger value of 100 L/kg (3.17 L/kg; Chemservice S.A., 2017). Due to the lack of a long-term toxicity potential, also the T criterion is not fulfilled. Furthermore, no classification exists as carcinogenic, mutagenic or toxic for reproduction according to Regulation (EC) No. 1272/2008. The test substance is neither classified as "T, R48" or as "Xn, R48" based on the criteria laid down in Directive 67/548/EEC nor as STOT RE category 1 or 2 so far.

As conclusion, Butylaminoethanol fulfils none of the relevant PBT/vPvB criteria and therefore, making all allowances for regulatory parameters available, the substance is neither PBT nor vPvB.

Likely routes of exposure:

Neither direct nor indirect exposure of the solely substance Butylaminoethanol to the environmental compartment is intended. Workers may be exposed via the dermal route due to substance handling during manufacture.